FDA.reportPublic FDA data

Acyclovir

Product NDC
71335-1290
11-digit product format
713351290
Labeler code
71335
Product ID
71335-1290_cb9a2970-e0e8-4faf-9ed9-06bec3649207
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206261
Marketing category
ANDA
Marketing start
2017-08-17
Substance
ACYCLOVIR
Active strength
200 mg/1
Pharmacologic classes
DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acyclovir
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACYCLOVIR200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui197310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33190c02-82e1-0a4d-d716-9ccd23588463Product name520250225
c367d1da-5a72-8966-6d11-1eb9a73ae758Product name320231115
5518bf13-db2f-2e9c-3679-e70ecf03752cProduct name920210614
27897900-0e40-497b-97e1-88057e68fe6cProduct name420200710
ca834e59-e669-229c-9288-0ccb76dc373eProduct name920200220
d7f95c49-d3e1-4bbc-a389-e9cd73f59a28Product name120190702
fb15b394-3715-4c87-a447-421489aa8739Product name320170727
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1290-02024-07-24C16284748780-11030e365-2b1d-111a-e063-dadaa90a10e2PRESCRIBING INFORMATION Acyclovir Capsules USP
71335-1290-12024-07-24C16284748780-11030e365-2b1d-111a-e063-dadaa90a10e2PRESCRIBING INFORMATION Acyclovir Capsules USP
71335-1290-22024-07-24C16284748780-11030e365-2b1d-111a-e063-dadaa90a10e2PRESCRIBING INFORMATION Acyclovir Capsules USP
71335-1290-32024-07-24C16284748780-11030e365-2b1d-111a-e063-dadaa90a10e2PRESCRIBING INFORMATION Acyclovir Capsules USP
71335-1290-42024-07-24C16284748780-11030e365-2b1d-111a-e063-dadaa90a10e2PRESCRIBING INFORMATION Acyclovir Capsules USP
71335-1290-52024-07-24C16284748780-11030e365-2b1d-111a-e063-dadaa90a10e2PRESCRIBING INFORMATION Acyclovir Capsules USP
71335-1290-62024-07-24C16284748780-11030e365-2b1d-111a-e063-dadaa90a10e2PRESCRIBING INFORMATION Acyclovir Capsules USP
71335-1290-72024-07-24C16284748780-11030e365-2b1d-111a-e063-dadaa90a10e2PRESCRIBING INFORMATION Acyclovir Capsules USP
71335-1290-82024-07-24C16284748780-11030e365-2b1d-111a-e063-dadaa90a10e2PRESCRIBING INFORMATION Acyclovir Capsules USP
71335-1290-92024-07-24C16284748780-11030e365-2b1d-111a-e063-dadaa90a10e2PRESCRIBING INFORMATION Acyclovir Capsules USP
71335-1290-02024-01-30C16284748780-11030e365-2b1d-111a-e063-dadaa90a10e2PRESCRIBING INFORMATION Acyclovir Capsules USP
71335-1290-12024-01-30C16284748780-11030e365-2b1d-111a-e063-dadaa90a10e2PRESCRIBING INFORMATION Acyclovir Capsules USP
71335-1290-22024-01-30C16284748780-11030e365-2b1d-111a-e063-dadaa90a10e2PRESCRIBING INFORMATION Acyclovir Capsules USP
71335-1290-32024-01-30C16284748780-11030e365-2b1d-111a-e063-dadaa90a10e2PRESCRIBING INFORMATION Acyclovir Capsules USP
71335-1290-42024-01-30C16284748780-11030e365-2b1d-111a-e063-dadaa90a10e2PRESCRIBING INFORMATION Acyclovir Capsules USP
71335-1290-52024-01-30C16284748780-11030e365-2b1d-111a-e063-dadaa90a10e2PRESCRIBING INFORMATION Acyclovir Capsules USP
71335-1290-62024-01-30C16284748780-11030e365-2b1d-111a-e063-dadaa90a10e2PRESCRIBING INFORMATION Acyclovir Capsules USP
71335-1290-72024-01-30C16284748780-11030e365-2b1d-111a-e063-dadaa90a10e2PRESCRIBING INFORMATION Acyclovir Capsules USP
71335-1290-82024-01-30C16284748780-11030e365-2b1d-111a-e063-dadaa90a10e2PRESCRIBING INFORMATION Acyclovir Capsules USP
71335-1290-92024-01-30C16284748780-11030e365-2b1d-111a-e063-dadaa90a10e2PRESCRIBING INFORMATION Acyclovir Capsules USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1290-0Acyclovir90 in 1 BOTTLECAPSULE907
71335-1290-1Acyclovir30 in 1 BOTTLECAPSULE307
71335-1290-2Acyclovir25 in 1 BOTTLECAPSULE257
71335-1290-3Acyclovir35 in 1 BOTTLECAPSULE357
71335-1290-4Acyclovir50 in 1 BOTTLECAPSULE507
71335-1290-5Acyclovir100 in 1 BOTTLECAPSULE1007
71335-1290-6Acyclovir40 in 1 BOTTLECAPSULE407
71335-1290-7Acyclovir60 in 1 BOTTLECAPSULE607
71335-1290-8Acyclovir120 in 1 BOTTLECAPSULE1207
71335-1290-9Acyclovir20 in 1 BOTTLECAPSULE207

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1290ACYCLOVIR CAPSULE [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 10 package rows20240915_01ae85df-d1a0-44f7-b4c0-0ac74d2216d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSN01ae85df-d1a0-44f7-b4c0-0ac74d2216d47
197310acyclovir 200 MG Oral CapsuleSCD01ae85df-d1a0-44f7-b4c0-0ac74d2216d47
197310acycycloguanosine 200 MG Oral CapsuleSY01ae85df-d1a0-44f7-b4c0-0ac74d2216d47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1290-07133512900090 CAPSULE in 1 BOTTLE (71335-1290-0) 90 capsule2024-09-050000-00-00NoNoCurrent
71335-1290-17133512900130 CAPSULE in 1 BOTTLE (71335-1290-1) 30 capsule2024-09-050000-00-00NoNoCurrent
71335-1290-27133512900225 CAPSULE in 1 BOTTLE (71335-1290-2) 25 capsule2019-08-210000-00-00NoNoCurrent
71335-1290-37133512900335 CAPSULE in 1 BOTTLE (71335-1290-3) 35 capsule2024-09-050000-00-00NoNoCurrent
71335-1290-47133512900450 CAPSULE in 1 BOTTLE (71335-1290-4) 50 capsule2024-09-050000-00-00NoNoCurrent
71335-1290-571335129005100 CAPSULE in 1 BOTTLE (71335-1290-5) 100 capsule2024-09-050000-00-00NoNoCurrent
71335-1290-67133512900640 CAPSULE in 1 BOTTLE (71335-1290-6) 40 capsule2024-09-050000-00-00NoNoCurrent
71335-1290-77133512900760 CAPSULE in 1 BOTTLE (71335-1290-7) 60 capsule2024-09-050000-00-00NoNoCurrent
71335-1290-871335129008120 CAPSULE in 1 BOTTLE (71335-1290-8) 120 capsule2024-09-050000-00-00NoNoCurrent
71335-1290-97133512900920 CAPSULE in 1 BOTTLE (71335-1290-9) 20 capsule2024-09-050000-00-00NoNoCurrent